A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00811135

Purpose

This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: capecitabine [Xeloda] Drug: trastuzumab [Herceptin] Drug: bevacizumab [Avastin]	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine Bevacizumab Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Arm Open-Label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-Line Treatment of Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Best overall response (% of patients with complete or partial response) [ Time Frame: Event driven; assessment made every 9-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival, overall survival, duration of response [ Time Frame: Event driven; assessments made every 9-12 weeks ] [ Designated as safety issue: No ]
Adverse events, cardiac events, laboratory tests [ Time Frame: Throughout study; assessments made very 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2012

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1000mg/m2 bid po on days 1-14 of each 3-week cycle Drug: trastuzumab [Herceptin] 8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles Drug: bevacizumab [Avastin] 15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
breast cancer with measurable locally recurrent or metastatic lesions;
candidate for chemotherapy;
HER2-positive disease;
ECOG PS of <=2.

Exclusion Criteria:

previous anticancer therapy for metastatic breast cancer;
previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment);
chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);
other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;
uncontrolled hypertension or significant cardiovascular disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811135

Contacts

Contact: Please reference Study ID Number: MO21926	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Denmark

HERLEV, Denmark, 2730

VEJLE, Denmark, 7100
France

PARIS, France, 75970

TOULOUSE, France, 31076

MARSEILLE, France, 13285

SAINT JEAN, France, 31240

CRETEIL, France, 94000

SAINT QUENTIN, France, 02321

LORMONT, France, 33310

DECHY, France, 59187

BEZIERS, France, 34525

AIX-EN-PROVENCE, France, 13616

RODEZ, France, 12000
Germany

FRANKFURT AM MAIN, Germany, 60596

DRESDEN, Germany, 01127

ULM, Germany, 89075

MÜNCHEN, Germany, 81377

GREIFSWALD, Germany, 17487

Kiel, Germany, 24103

MÜNCHEN, Germany, 80673

GIFHORN, Germany, 38518

MÖNCHENGLADBACH, Germany, 41061
Russian Federation

MOSCOW, Russian Federation, 115478

ST PETERSBURG, Russian Federation, 197758

MOSCOW, Russian Federation, 143423
Slovakia

BRATISLAVA, Slovakia, 831 01
Sweden

UPPSALA, Sweden, 75185

ESKILSTUNA, Sweden, 63188

VAXJO, Sweden, 35185

SUNDSVALL, Sweden, 85186

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MO21926, 2008-003283-20
Study First Received:	December 16, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00811135
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Study placed in the following topic categories:

Capecitabine
Skin Diseases
Trastuzumab
Breast Neoplasms

Bevacizumab
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009